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Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1

Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03818594
Acronym
VITAD/1
Enrollment
338
Registered
2019-01-28
Start date
2019-01-08
Completion date
2020-09-28
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Serum Levels

Brief summary

Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults using longitudinal study design, and association between vitamin D status and different Caucasian phototypes, skin colour and melanin index investigated .

Interventions

None listed

Sponsors

VIST - Faculty of Applied Sciences
CollaboratorOTHER
Slovenian Research Agency
CollaboratorOTHER
Valens Int. d.o.o., Slovenija
CollaboratorINDUSTRY
Institute of Nutrition, Slovenia (Nutris)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Signed Informed consent form (ICF), * Caucasian race * Age between 18 and 65 years at the time of the signature of Informed consent form (ICF), * Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources * Willingness to follow all study procedures

Exclusion criteria

* Pregnancy or breastfeeding, * Known or suspected allergy to any ingredient of the tested products in Part 2, * Pronounced avoidance of sunshine (eg reporting of allergy to the sun) * Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion, * Special dietary habits used by a small part of the population (veganism, low-carb hihg-fat diet, caloric restriction diet, note: vegetarians are not excluded) * Diets prescribed by the medical profession * Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases * Other diseases and conditions that affect the absorption and synthesis of vitamin D * Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium), * The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D, * Visiting the solarium in the last three months before joining the survey, * Mental incapacity that precludes adequate understanding or cooperation.

Design outcomes

Primary

MeasureTime frameDescription
Difference between vitamin D serum levels in winter and in summer season will be determined2 yearsVitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.

Secondary

MeasureTime frameDescription
Correlation of vitamin D serum levels with Fitzpatrick skin phototype2 yearsFitzpatrick skin phototype will be determined using Fitzpatrick self-evaluation questionnaire in combination with expert assessment in August-September.
Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space2 yearsSkin colour will be measured in CIE Lab colour space on inner and outer side of the upper arm. The measurement will be performed in August-September.
Correlation of vitamin D serum levels with melanin index2 yearsMelanin index will be measured on inner and outer side of the upper arm. The measurement will be performed in August-September.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026